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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K080280
Device Name SUB-TALAR LOK, MODEL 7-11 MM
Applicant
Instratek, Inc.
210 Springhill Dr.
Suite 130
Spring,  TX  77386
Applicant Contact Jeff Seavey
Correspondent
Instratek, Inc.
210 Springhill Dr.
Suite 130
Spring,  TX  77386
Correspondent Contact Jeff Seavey
Regulation Number888.3040
Classification Product Code
HWC  
Date Received02/04/2008
Decision Date 03/14/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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